RELUGOLIX Myfembree for Endometriosis Pain in Premenopausal Women Instructions

Myfembree for Endometriosis Pain in Premenopausal Women
Instructions STANDARD COMMERCIAL DRUG FORMULARY
PRIOR AUTHORIZATION GUIDELINES

RELUGOLIX-ESTRADIOL-NORETHINDRONE

Generic| Brand| HICL| GCN| Medi-Span| Exception/Other
---|---|---|---|---|---
RELUGOLIX/ESTRADIOL/NORETHINDRONE ACETATE| MYFEMBREE| 47392| | GPI-10 (2499350380)|

GUIDELINES FOR USE

**INITIAL CRITERIA

**

( NOTE: FOR RENEWAL CRITERIA SEE BELOW)

1. Has the patient received a total of 24 months of cumulative treatment with Myfembree?
   If yes, do not approve.
   DENIAL TEXT: See the initial denial text at the end of the guideline.
   If no, continue to #2.

2. Is the request for the management of heavy menstrual bleeding associated with uterine leiomyomas(fibroids) and the patient meets ALL the following criteria?
   • The patient is 18 years of age or older
   • The patient is a premenopausal woman
   • Therapy is prescribed by or in consultation with an obstetrician or gynecologist (OB/GYN)
   If yes, approve for 6 months by HICL or GPI-10 with a quantity limit of #1 per day.
   If no, continue to #3.

3. Is the request for the management of moderate to severe pain associated with endometriosis and Does the patient meet ALL of the following criteria?
   • The patient is 18 years of age or older
   • The patient is a premenopausal woman
   • Therapy is prescribed by or in consultation with an obstetrician or gynecologist (OB/GYN)
   • The patient’s diagnosis is confirmed via surgical or direct visualization (e.g., pelvic ultrasound) or histopathological confirmation (e.g., laparoscopy or laparotomy) in the last 10 years
   • Myfembree will NOT be used concurrently with another GnRH-modulating agent (e.g., Orilissa, Lupron Depot, Synarel)

If yes, approve for 6 months by HICL or GPI-10 with a quantity limit of #1 per day.
If no, do not approve.
DENIAL TEXT: See the initial denial text at the end of the guideline.
INITIAL DENIAL TEXT: *Some terms are already pre-defined in parenthesis. Please use these definitions if the particular text you need to use does not already have a definition(s) in it.
Our guideline named RELUGOLIX-ESTRADIOL-NORETHINDRONE (Myfembree) requires the following rule(s) be met for approval:
A. The request is for ONE of the following:

1. Management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids: non-cancerous growths in the uterus)
2. Management of moderate to severe pain associated with endometriosis (a condition affecting the uterus)

B. If the request is for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids), approval also requires:

1. You are 18 years of age or older
2. You are a premenopausal (before menopause) woman
3. Therapy is prescribed by or in consultation with an obstetrician or gynecologist (OB/GYN: a type of women’s health doctor)
4. You have not received a total of 24 months of cumulative (total) treatment with Myfembree

C. If the request is for the management of moderate to severe pain associated with endometriosis, approval also requires:

1. You are 18 years of age or older
2. You are a premenopausal (before menopause) woman
3. Therapy is prescribed by or in consultation with an obstetrician or gynecologist (OB/GYN: a type of women’s health doctor)
4. Your diagnosis of endometriosis is confirmed via surgical or direct visualization (such as pelvic ultrasound [type of imaging]) or histopathological (tissue) confirmation (such as laparoscopy [type of surgery] or laparotomy [type of surgery]) in the last 10 years
5. Myfembree will NOT be used concurrently (at the same time) with another GnRHmodulating agent (such as Orilissa, Lupron Depot, Synarel)
6. You have not received a total of 24 months of cumulative (total) treatment with Myfembree

Your doctor told us [INSERT PT SPECIFIC INFO PROVIDED]. We do not have information showing you [INSERT UNMET CRITERIA]. This is why your request is denied. Please work with your doctor to use a different medication or get us more information if it will allow us to approve this request.

RENEWAL CRITERIA

1. Has the patient received a total of 24 months of cumulative treatment with Myfembree?
   If yes, do not approve.
   DENIAL TEXT: See the renewal denial text at the end of the guideline.
   If no, continue to #2.

2. Is the request for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) AND the patient meets the following criterion?
   • The patient has had improvement of heavy menstrual bleeding
   If yes, approve for 18 months (or up to 24 months cumulative lifetime treatment duration) by HICL or GPl-10 with a quantity limit of #1 per day.
   If no, continue to #3.

3. Is the request for the management of moderate to severe pain associated with endometriosis and the patient meets ALL of the following criteria?
   • The patient has had improvement in pain related to endometriosis
   • Myfembree will NOT be used concurrently with another GnRH-modulating agent (e.g., Orilissa, Lupron Depot, Synarel)

If yes, approve for 18 months (or up to 24 months cumulative lifetime treatment duration) by HICL or GPL-10 with a quantity limit of #1 per day.
If no, do not approve.
RENEWAL DENIAL TEXT: *Some terms are already pre-defined in parenthesis. Please use these definitions if the particular text you need to use does not already have a definition(s) in it.
Our guideline named RELUGOLIX-ESTRADIOL-NORETHINDRONE (Myfembree) requires the following rule(s) be met for renewal:
A. The request is for ONE of the following:

1. Management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids: non-cancerous growths in the uterus)
2. Management of moderate to severe pain associated with endometriosis (a condition affecting the uterus)

B. If the request is for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids), renewal also requires:

1. You had an improvement in heavy menstrual bleeding during therapy
2. You have not received a total of 24 months of cumulative (total) treatment with Myfembree

C. If the request is for the management of moderate to severe pain associated with endometriosis, renewal also requires:

1. You have had improvement in pain related to endometriosis while on therapy
2. Myfembree will NOT be used concurrently (at the same time) with another GnRHmodulating agent (such as Orilissa, Lupron Depot, Synarel)
3. You have not received a total of 24 months of cumulative (total) treatment with Myfembree

Your doctor told us [INSERT PT SPECIFIC INFO PROVIDED]. We do not have information showing you [INSERT UNMET CRITERIA]. This is why your request is denied. Please work with your doctor to use a different medication or get us more information if it will allow us to approve this request.

RATIONALE
For further information, please refer to the Prescribing Information and/or Drug Monograph for Myfembree.
REFERENCES

• Myfembree [Prescribing Information]. Brisbane, CA: Myovant Sciences, Inc., August 2022.

Part D Effective : N/A
Commercial Effective: 09/12/22
Created: 06/21
Client Approval: 08/22
P &T Approval: 04/22

Copyright © 2022 MedImpact Healthcare Systems, Inc. All rights reserved.
This document is proprietary to MedImpact.
MedImpact maintains the sole and exclusive ownership, right, title, and interest in and to this document.
Revised: 8/19/2022

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